01 1[Partial manufacturing plant (crude ruxolitinib phosphate manufacturing)] Ampac Fine Chemicals LLC@[Partial manufacturing plant (crude ruxolitinib phosphate recrystallization)] Sterling Pharma Ringaskiddy Limited@[Partial manufacturing plant (sieving proc
01 1Novartis Korea Ltd.
01 1Luxolitinib phosphate
01 1U.S.A
Registrant Name : Novartis Korea Ltd.
Registration Date : 2016-11-24
Registration Number : No. 196-15-ND
Manufacturer Name : [Partial manufacturing plant...
Manufacturer Address : Highway 50 and Hazel Avenue, Rancho Cordova, CA 95670, USA@Ringaskiddy, Cork, P43 FR6...
A Ruxolitinib Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ruxolitinib Phosphate, including repackagers and relabelers. The FDA regulates Ruxolitinib Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ruxolitinib Phosphate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ruxolitinib Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ruxolitinib Phosphate supplier is an individual or a company that provides Ruxolitinib Phosphate active pharmaceutical ingredient (API) or Ruxolitinib Phosphate finished formulations upon request. The Ruxolitinib Phosphate suppliers may include Ruxolitinib Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Ruxolitinib Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ruxolitinib Phosphate Drug Master File in Korea (Ruxolitinib Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ruxolitinib Phosphate. The MFDS reviews the Ruxolitinib Phosphate KDMF as part of the drug registration process and uses the information provided in the Ruxolitinib Phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ruxolitinib Phosphate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ruxolitinib Phosphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ruxolitinib Phosphate suppliers with KDMF on PharmaCompass.
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